Many women in the UK– and other countries – remain unaware that they carry illegal silicone breast implants made by French maker Poly Implant Prothèse (PIP), marketed under a different brand, Clinica has learned.
Evidence has emerged that PIP implants rebranded by Dutch firm Rofil Medical have been widely used by “health tourism” clinics around the world. This means that the number of women affected by the PIP fraud internationally – officially 50,000 in the UK alone and 30,000 in France, for example – is likely to be significantly greater than previously thought.
Since PIP warnings do not mention the Rofil rebranding, these women remain largely unaccounted for and unprotected in terms of follow-up care. The health risks for these PIP implantees could become even more serious if the filler proves to be genotoxic in ongoing tests by French regulatory agency Afssaps.
Clinica was alerted to the unaddressed risk to Rofil implantees when a UK patient contacted to ask whether M-implants should be considered as hazardous as PIP. She cited Clinica’s article (www.clinica.co.uk, 18 August 2010) onPortugal’s response to an alert issued by Dutch regulator IGZ in April 2010. In its alert, IGZ reported that Breda-based Rofil Medical Nederland had bought PIP’s fraudulent implants and resold them internationally under the name “M-implant”.
The patient was implanted in Brusselsin 2006 and found out in July 2008 that both implants had ruptured, probably some time earlier. The implants were found to be surrounded by scar tissue and, in the belief that they posed no major risk, she opted to not explant them, though silicone had already been found in a number of lymph nodes, which were then removed. She changed her mind in response to Clinica‘s coverage, and is about to undergo urgent replacement surgery.
She is one of an estimated 5,000UKwomen who travel abroad for breast augmentation annually.
The British Association of Aesthetic and Plastic Mechanics (BAAPS) believes that the Rofil rebranding poses a significant new concern, noting that PIP implants were “known to have been popular with the larger domestic chains and commercial clinics because of their low cost”. Yet, the extent of the presence of these rebranded implants appears to have been ignored by most regulatory agencies, on the basis that they were not distributed in their respective countries.
“The discovery that the rupture-prone products were also sold in countries such asBelgiumand [other leading cosmetic surgery destinations] under the rebranded name Rofil M-implant could mean that the number of women who should be on the alert is much higher,” a spokesperson said.
“PIP advice to be extended” – BAAPS
In light of Clinica’s findings, BAAPS said it will now issue a warning to women who have travelled abroad for breast augmentation. Citing the current advice on PIP, the association’s president, Fazel Fatah, said the association would “reiterate its advice and extend it to women who may have gone abroad for their surgery”.
The international guidelines for women with PIP implants – whether or not these have ruptured – is to undergo immediate examination to assess the condition of the implant shell, followed by regular checks, including MRI scans. Ruptured implants should be removed immediately; women with one ruptured implant are advised to have both removed.
This is provisional advice, subject to ongoing genotoxicity tests on the filler. French regulator Afssaps has said it expects to publish the results in “early 2011” and, if they show an increased risk of harm, then the advice will likely be to recommend immediate explantation in all cases.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) did not reissue the IGZ’s warning for theUK– and thereby extend its PIP guidance to Rofil implantees – on the basis that the rebranded devices were deemed not to have been supplied in theUK. The agency stands by this position.
“The MHRA has no evidence to suggest that any Rofil-branded silicone breast implants were implanted in the UK,” the agency told Clinica. “The MHRA’s remit is to ensure the safety of devices implanted in theUK. We do not therefore consider it necessary to alter our advice.”
Rofil escalation – a new global regulatory challenge
The Rofil rebranding problem affects many countries within the EU and around the world, but onlyPortugalappears to have publicly alerted its healthcare system to the problem (www.clinica.co.uk, 18 August 2010). This was apparently due to Rofil appearing in patients who had undergone operations abroad. Portuguese regulator Infarmed said that Rofil-rebranded PIP implants had not been supplied in the country.
In Franceand Spain, PIP patient support groups and experts representing them in these countries, have told Clinica that they are unaware of the existence of Rofil-branded PIPs or of the history surrounding them.
However, health tourism websites have been advertising Rofil silicone gel implants or listing their suppliers throughout the last decade, in particular between 2003 and 2009. This is true of some of the most popular destinations such as the CzechRepublic, Polandand the Far East, but also even in the US, Clinica can reveal (further details to follow, subject to discussions with the FDA).
Clinica cannot confirm whether the implants marketed by these sites were fraudulent or unsafe, but they were being marketed within the timeframe of the PIP ban and appear to fall under IGZ’s Rofil M-implant alert of April 2010, in terms of the type of implants involved, namely “cohesive silicone gel” and their marketing descriptions.
So far, the focus of this crisis has been the implants sold by PIP directly in at least 65 countries over nine years (www.clinica.co.uk, 13 May 2010). However, the growing evidence that Rofil-branded PIP silicone implants have been supplied to the health tourism industry around the world is a major source of concern, by leaving many women unaccounted for in health protection advice and follow-up care.
The situation suggests the need for a radical rethink of national and international surveillance and alerting policies, as well as an immediate review of PIP-related guidance to reflect the rebranding problem.
Clinica Medtech Intelligence, 15.2.11